10-K annual report · filed Feb 27, 2026

Align Technology (ALGN) FY2025 10-K Annual Report

Short answer

Align Technology (ALGN) filed its fiscal 2025 10-K annual report with the SEC on Feb 27, 2026. It reported revenue of $4.0B (+0.9% year over year) and net income of $410M.

  • Top risk flagged: Section 232 investigation by U.S. Dept of Commerce into PPE/medical device imports directly threatens Align's Mexico-manufactured clear aligners shipped to U.S.

FY2025 key financial metrics · XBRL

Revenue
$4.0B
+0.9% YoY
Net income
$410M
−2.6% YoY
Operating margin
13.5%
−1.7 pp YoY
Gross margin
67.2%
−2.8 pp YoY
EPS (diluted)
$5.65
+0.5% YoY
ROE
10.1%
−0.8 pp YoY
Operating cash flow
$593M
−19.6% YoY

Source: XBRL data from the Align Technology (ALGN) FY2025 10-K on SEC EDGAR. USD.

Align Technology FY2025 10-K analysis

AI summary of each section, grounded in the filing text

Business Overview

  • Global med-device co: design/manufacture/market Invisalign clear aligners (~80% revenue), iTero scanners, and exocad CAD/CAM software via integrated Align Digital Platform
  • 2025 new launches: iTero Lumina Pro with NIRI technology (March), Align X-ray Insights AI-based caries detection in EU/UK (March), Invisalign MAOB for Class II teen patients (December)
  • Direct fabrication via Cubicure (acquired Jan 2024) scaling toward millions of 3D-printed devices/day; retainers and pre-fab attachments pilot releases planned 2026
  • Headcount ~20,290 as of Dec 31, 2025: down 3.1% YoY and 6.1% vs 2023, signaling ongoing workforce contraction despite product expansion
  • Invisalign holds only ~10% share of ~22M annual global orthodontic case starts: massive untapped market framing core growth narrative

Management Discussion & Analysis

  • Revenue $4,035M, up 0.9% YoY ($+$36M); Clear Aligner +0.5% to $3,245M, Systems & Services +2.7% to $790M
  • Gross margin 67.2% vs 70.0%; operating margin 13.5% vs 15.2%; Clear Aligner margin 31.9% vs 35.4%; Systems & Services margin 38.8% vs 35.0%
  • Best segment: Systems & Services op margin 38.8% vs 35.0%; worst: Clear Aligner dragged by $77M accelerated depreciation and ASP decline 3.9% ($1,245 vs $1,295)
  • Operating cash flow $593M vs $738M YoY; capex $102M; buybacks $466M; $831M remaining under repurchase program; no dividends
  • Key risks: tariff volatility, macro uncertainty dampening discretionary spending, orthodontic starts down four consecutive years; FY2026 capex guided $125–$150M

Risk Factors

  • Section 232 investigation by U.S. Dept of Commerce into PPE/medical device imports directly threatens Align's Mexico-manufactured clear aligners shipped to U.S.
  • iTero HQ in Israel near Hamas conflict zone; Mexico manufacturing exposed to drug cartel/gang activity disrupting production and logistics
  • Heavy dependence on sole-source suppliers for specialized resin, rapid prototyping machines, and iTero optics components with no quick replacement path
  • Competitors integrating AI/ML into orthodontic workflows risk commoditizing Invisalign; DTC aligner companies bypassing doctor channel further erode pricing power
  • Revenue concentrated in Invisalign System as primary revenue driver; restructuring plans executed three consecutive fiscal years signal persistent operational instability

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